Catalog Number

-

Brand Name

Clinical Guard

Version/Model Number

Pregnancy Urine Test Strip Pack of 20

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

LCX

Product Code Name

Kit, Test, Pregnancy, Hcg, Over The Counter

Public Device Record Key

84122c2c-ddc3-4da1-9b90-7fa046313c3c

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

December 20, 2017

Package DI Number

10897429002855

Quantity per Package

250

Contains DI Package

00897429002858

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-